Efficacy of Sacral Nerve Stimulation for the Treatment of Fecal Incontinence

BACKGROUND: Sacral nerve stimulation has been shown to be an effective treatment for fecal incontinence and early studies reported success rates of 67% to 100%. However, "success" has been arbitrarily set at a 50% reduction in symptoms, and data are rarely reported with "intention to treat." OBJECTIVE: This study aimed to assess the true efficacy of sacral nerve stimulation for fecal incontinence compared with the published literature. DESIGN: This prospective 5-year study was conducted to assess 50 patients with fecal incontinence treated with sacral nerve stimulation. All analyses were performed on an intention-to-treat basis. SETTINGS: This study took place in a single tertiary referral colorectal department. PATIENTS: Fifty consecutive patients with fecal incontinence refractory to conservative management were included in the study. INTERVENTIONS: The interventions performed were temporary evaluation with or without permanent sacral nerve stimulation. MAIN OUTCOME MEASURES: Primary outcome measures were 1) attainment of continence, 2) reduction in fecal incontinence episodes, 3) improvement in Cleveland Clinic Fecal Incontinence scores, and 4) improvement in the ability to defer defecation. RESULTS: Thirteen patients (26%) did not respond at the temporary evaluation stage or were dissatisfied with the result. Ten further patients (20%) did not achieve a 50% reduction in symptoms following permanent implantation. The median follow-up was 17 months (range, 2-55), at which time 27 patients (54%) experienced a 50% or more reduction in symptoms, including 13 (26%) who achieved apparent continence. Median fecal incontinence episodes per fortnight reduced from 14 (range, 0-53) to 2 (range, 0-20; P < .0001). Median Cleveland Clinic Fecal Incontinence scores reduced from 15 (range, 3-20) to 8 (range, 0-17; P < .0001). The ability to defer defecation improved significantly (P < .0001). These results compare favorably with the published literature. LIMITATIONS: Quality of life was not assessed. CONCLUSIONS: This study demonstrates that sacral nerve stimulation can be an effective treatment for patients with fecal incontinence; however, when analyzed by intention to treat, the symptoms of fecal incontinence continue in the majority (74%) of patients.